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Regulatory Affairs Associate I

Regulatory Affairs Associate I

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Watson Pharama

1 - 3 years

6 - 7 Lacs

mumbai navi mumbai

Posted:-1 days ago| Platform:

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Skills Required

ectd pharmaceutical regulatory submissions usfda technical regulatory anda ich veeva ra regulatory publishing ctd system nees writing regulatory affairs adobe acrobat life sciences drug regulatory affairs dmf vault isi toolbox us market

Work Mode

Work from Office

Job Type

Full Time

Job Description

Regulatory Affairs Associate I Job Details | Teva Pharmaceuticals

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Find a Career With Purpose at Teva

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Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate I Nov 3, 2025 Navi Mumbai, India, 400706

Who we are

The opportunity

Regulatory Affairs associate I RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate

How you ll spend your day

Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
Collaborate with scientific personnel for planning, preparation and publishing
Maintain working knowledge of internal and external publishing standards.
Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

Your experience and qualifications

B. Pharm/M. Pharm/ Master of Life Sciences.
Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
Command over spoken and written English
Sensitivity to the cultural diversity of a global organization
Good understanding of regulatory IT systems

Reports To

Manager Regulatory Submission Management

Teva s Equal Employment Opportunity Commitment

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Regulatory Affairs Associate I